MAUDE Adverse Event Report: NEUMODX MOLECULAR NEUMODX SARS-COV-2 TEST STRIP; SARS-COV-2-COVID-19

Model Number	100100
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No adverse outcomes were reported.Investigation confirmed a product malfunction.We are reporting this event in an abundance of caution due to the impact on two eua assays.
Event or Problem Description
False positive results for neumodx sars-cov-2 on the neumodx 288 molecular system.
Additional Manufacturer Narrative
This is a follow up report for 3010729479-2021-00007 to change the product code.A recall report has been submitted to fda on may 14, 2021.

• Brand Name: NEUMODX SARS-COV-2 TEST STRIP
• Common Device Name: SARS-COV-2-COVID-19
• Manufacturer (Section D): NEUMODX MOLECULAR; 1250 eisenhower place; ann arbor MI 48108
• MDR Report Key: 11815533
• Report Number: 3010729479-2021-00007
• Device Sequence Number: 19878574
• Product Code: QJR
• UDI-Device Identifier: 10814278020274
• UDI-Public: 10814278020274
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EUA200073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/26/2022
• Device Model Number: 100100
• Device Catalogue Number: 300800
• Device Lot Number: 106629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3010729479-05122021-001
• Patient Sequence Number: 1